■重大挑战与血脂异常的药物管理有关,心血管疾病的重要危险因素。关于含有红曲米(RYR)的商业中草药制剂(CCPP)的功效,存在有限的可靠证据,尽管它们在中国广泛使用。
■我们旨在研究含RYR的CCPPs联合他汀类药物治疗血脂异常的疗效。
■从数据库开始日期到2023年11月,在八个数据库中搜索相关的随机对照试验(RCT)。成果措施,包括低密度脂蛋白胆固醇(LDL-C),高密度脂蛋白胆固醇(HDL-C),总胆固醇(TC),甘油三酯(TG),临床疗效,和不良反应,被评估。Cochrane干预措施系统审查手册用于质量评估,使用RevMan5.3和Stata15.1进行荟萃分析。
■纳入了33项研究,涉及4,098名参与者。含RYR的CCPP的组合,如血脂康(XZK),Zhibitai(ZBTAI),或Zhibituo(ZBTUO)与他汀类药物对临床疗效的增加有显着影响[RR:1.16,95CI(1.13,1.19),p<0.00001]。此外,他们还通过增加HDL-C水平来改善血脂参数[MD:0.21,95CI(0.17,0.25),p<0.00001],并降低TC[MD:0.60,95CI(-0.76,-0.45),p<0.00001],TG[MD:0.33,95CI(-0.39,-0.26),p<0.00001]和LDL-C水平[MD:0.45,95CI(-0.54,-0.36),p<0.00001]。在含RYR的CCPPs中未观察到明显的不良反应。值得注意的是,ZBTAI和XZK可显着降低胃肠道紊乱和肌肉不良反应的发生率。然而,亚组分析表明,CCPPs的类型,剂量,和治疗持续时间可能会影响含RYR的CCPPs的疗效。
■含RYR的CCPPs联合他汀类药物似乎可以改善血脂异常患者的血脂状况和临床疗效。然而,由于纳入研究的质量差,一些研究显示阴性结果未发表。在通过精心设计的RCT进一步确认之前,应谨慎解释结果。
■https://www.crd.约克。AC.uk/prospro/display_record.php?RecordID=487402,标识符CRD42023487402。
UNASSIGNED: Significant challenges are associated with the pharmacological management of dyslipidemia, an important risk factor for cardiovascular disease. Limited reliable evidence exists regarding the efficacy of red yeast rice (RYR)-containing commercial Chinese polyherbal preparation (CCPP), despite their widespread use in China.
UNASSIGNED: We aimed to investigate the efficacy of RYR-containing CCPPs combined with statins in treating dyslipidemia.
UNASSIGNED: Eight databases were searched for relevant randomized controlled trials (RCTs) from database inception date to November 2023. Outcome measures, including low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), triglyceride (TG), clinical efficacy, and adverse reactions, were assessed. The Cochrane Handbook for Systematic Reviews of Interventions was used for quality evaluation, and the meta-analysis was conducted using RevMan 5.3 and Stata 15.1.
UNASSIGNED: Thirty-three studies involving 4,098 participants were included. The combination of RYR-containing CCPP, such as Xuezhikang (XZK), Zhibitai (ZBTAI), or Zhibituo (ZBTUO) with statins had a significant effect on the increase in clinical efficacy [RR:1.16, 95%CI (1.13, 1.19), p < 0.00001]. In addition, they also improved blood lipid profile parameters by increasing HDL-C levels [MD:0.21, 95%CI(0.17, 0.25), p < 0.00001], and decreasing TC [MD: 0.60, 95%CI(-0.76, -0.45), p < 0.00001], TG [MD: 0.33, 95%CI(-0.39, -0.26), p < 0.00001] and LDL-C levels [MD: 0.45, 95%CI(-0.54, -0.36), p < 0.00001]. No significant adverse reactions was observed in the RYR-containing CCPPs. Notably, ZBTAI and XZK significantly reduced the incidence of gastrointestinal disturbances and muscular adverse reactions. However, subgroup analyses suggested that the type of CCPPs, dose, and treatment duration might affect the efficacy of RYR-containing CCPPs.
UNASSIGNED: RYR-containing CCPPs combined with statins appears to improve lipid profiles and clinical efficacy in patients with dyslipidemia. However, due to the poor quality of the included studies, and some studied showing negative findings was unpublished. The results should be interpreted with caution until further confirmation by well-designed RCTs.
UNASSIGNED: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=487402, identifier CRD42023487402.